Open AccessPlatelet inhibition to target reperfusion injury trial: Rationale and study design
Author(s) -
Bulluck Heerajnarain,
Chan Mervyn H. H.,
Bryant Jennifer A.,
Chai Ping,
Chawla Ashish,
Chua Terrance S.,
Chung YiuCho,
Fei Gao,
Ho Hee H.,
Ho Andrew F. W.,
Hoe Andrew J.,
Imran Syed S.,
Lee ChiHang,
Lim Swee H.,
Liew Boon W.,
Yun Patrick L. Z.,
Hock Marcus O. E.,
Paradies Valeria,
Roe Matthew T.,
Teo Lynette,
Wong Aaron S.,
Wong Evelyn,
Wong Philip E.,
Watson Timothy,
Chan Mark Y.,
Tan Jack W.,
Hausenloy Derek J.
Publication year - 2019
Publication title -
clinical cardiology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.263
H-Index - 72
eISSN - 1932-8737
pISSN - 0160-9289
DOI - 10.1002/clc.23110
Subject(s) - medicine , cangrelor , percutaneous coronary intervention , cardiology , myocardial infarction , p2y12 , clinical endpoint , reperfusion therapy , reperfusion injury , conventional pci , anesthesia , randomized controlled trial , ischemia
Background In ST‐segment elevation myocardial infarction (STEMI) patients treated with primary percutaneous coronary intervention (PPCI), current oral P2Y12 platelet inhibitors do not provide maximal platelet inhibition at the time of reperfusion. Furthermore, administration of cangrelor prior to reperfusion has been shown in pre‐clinical studies to reduce myocardial infarct (MI) size. Therefore, we hypothesize that cangrelor administered prior to reperfusion in STEMI patients will reduce the incidence of microvascular obstruction (MVO) and limit MI size in STEMI patients treated with PPCI. Methods The platelet inhibition to target reperfusion injury (PITRI) trial, is a phase 2A, multi‐center, double‐blinded, randomized controlled trial, in which 210 STEMI patients will be randomized to receive either an intravenous (IV) bolus of cangrelor (30 μg/kg) followed by a 120‐minute infusion (4 μg/kg/min) or matching saline placebo, initiated prior to reperfusion (NCT03102723). Results The study started in October 2017 and the anticipated end date would be July 2020. The primary end‐point will be MI size quantified by cardiovascular magnetic resonance (CMR) on day 3 post‐PPCI. Secondary endpoints will include markers of reperfusion, incidence of MVO, MI size, and adverse left ventricular remodeling at 6 months, and major adverse cardiac and cerebrovascular events. Summary The aim of the PITRI trial is to assess whether cangrelor administered prior to reperfusion would reduce acute MI size and MVO, as assessed by CMR.